FDA Just Says No To Generic, Crushable Versions Of OxyContin

The U.S. Food and Drug Administration doesn’t want to make it too easy for people who might abuse the powerful painkiller OxyContin, and has such has declared that generic drug manufacturers cannot produce their own, crushable versions of the drug.

The patent on OxyContin was set to expire yesterday, prompting concerns among many that people who wanted to use the drug in an inappropriate manner would be be able to get their hands on it more easily.

“The FDA will not approve any generics to the original formulation of OxyContin,” said FDA spokeswoman Morgan Liscinsky, according to theCourier-Journal.

Back in 2010, Purdue Pharma, the drug’s maker, came out with a pill form that can’t be crushed and injected, thus maintaining its slow release action into the body. When one of the new kinds of pills gets smushed, it turns into a gummy substance that won’t cooperate with a needle.

In Kentucky, prescription-pill abuse is a big worry, causing nearly 1,000 deaths among the state’s residents every year.

Kentucky Attorney General Jack Conway said in a statement he was “extremely pleased that the FDA heeded the bipartisan advice of state attorneys general and policymakers throughout Kentucky and elsewhere. To have allowed generic, crushable oxycontin on the market would have been a serious step backwards in our efforts against opiate painkiller abuse.”

And of course, it’s a win for Purdue Pharma, as the generic companies will have to put in extra work to create non-crushable formulas before they can sell a version of OxyContin.

Generic Pharmaceutical hasn’t issued a response yet, but the association’s senior vice president for science and regulation told the paper a few months ago that preventing generic drugs from hitting the market comes at the expense of patients in need of cheaper versions of those drugs.

“We see a very strong need for these products that are not tamper-resistant,” he said, and if those kinds of products aren’t allowed, legitimate patients are forced to pay more.